NEW YORK, Aug. 27, 2025 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (NASDAQ: UNCY) and certain officers.  The class action, filed in the United States District Court Northern District of California, and docketed under 25-cv-06923, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Unicycive securities between March 29, 2024 and June ...

NEW YORK, Aug. 25, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (NASDAQ: UNCY) and certain officers. The class action, filed in the United States District Court Northern District of California, and docketed under 25-cv-06923, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Unicycive securities between March 29, 2024 and J ...

Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In Unicycive (UNCY) To Contact Him Directly To Discuss Their Options Before the October 14th Deadline. If you purchased or acquired stock in Unicycive between March 29, 2024 and June 27, 2025 and would like to discuss your legal rights, call Bragar Eagel & Squire partner Brandon Walker or Marion Passmore directly at (212) 355-4648. Click here to participate in the action. NEW YORK, Aug. 23, 2025 (GLOBE NEW ...

Core Viewpoint - A securities class action lawsuit has been filed against Unicycive Therapeutics, Inc. for alleged violations of the Securities Exchange Act of 1934, specifically regarding misleading statements about the company's FDA compliance and drug candidate prospects [1][2]. Summary by Relevant Sections Lawsuit Details - The lawsuit is on behalf of all individuals and entities who purchased Unicycive securities between March 29, 2024, and June 7, 2025 [1]. - Allegations include false statements regarding the company's readiness to meet FDA manufacturing compliance requirements [2]. - The suit also claims misleading information about the regulatory prospects of the lead drug candidate, oxylanthanum carbonate (OLC), for treating hyperphosphatemia in chronic kidney disease patients on dialysis [3]. Key Events - In September 2024, Unicycive submitted its New Drug Application (NDA) for OLC to the FDA [7]. - On June 10, 2025, the company disclosed that the FDA found deficiencies in cGMP compliance at a third-party manufacturing subcontractor, leading to a stock drop of 40.9% to $5.32 [7]. - On June 30, 2025, the FDA issued a Complete Response Letter (CRL) rejecting the OLC NDA due to the same cGMP issues, causing the stock to fall another 29.9% to $4.77 [7]. - Investors must seek lead plaintiff appointment by October 14, 2025 [7].

Core Viewpoint - A class action has been filed against Unicycive Therapeutics, Inc. for allegedly misleading investors regarding the readiness of its drug application and compliance with FDA manufacturing requirements [1][2]. Group 1: Allegations and Legal Action - Robbins LLP is investigating allegations that Unicycive Therapeutics misled investors about the prospects of its New Drug Application (NDA) for oxylanthanum carbonate (OLC) [2]. - The complaint claims that Unicycive overstated its readiness to meet FDA manufacturing compliance requirements [2]. - Shareholders are encouraged to participate in the class action and can contact Robbins LLP before the October 14, 2025 deadline to serve as lead plaintiff [4]. Group 2: Stock Performance and FDA Actions - On June 10, 2025, Unicycive announced that the FDA identified deficiencies in cGMP compliance at a third-party manufacturing vendor, leading to a stock price drop of over 40% [3]. - Following the FDA's issuance of a Complete Response Letter for the OLC NDA on June 30, 2025, Unicycive's stock fell nearly 30%, closing at $4.77 per share [3].

LOS ALTOS, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the publication of pivotal trial data describing the safety and tolerability of oxylanthanum carbonate (OLC) in chronic kidney disease (CKD) patients on dialysis in the Clinical Journal of the American Society of Nephrology. The publication, entitled “A Phase 2 Clinical Tr ...

Core Viewpoint - The FDA has identified deficiencies in cGMP compliance at a third-party manufacturing vendor for Unicycive Therapeutics' New Drug Application (NDA) for oxylanthanum carbonate (OLC), with a final decision expected by June 28, 2025 [1][2]. Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney disease, with its lead investigational treatment being oxylanthanum carbonate (OLC) [6]. - OLC is an oral phosphate binder designed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, utilizing proprietary nanoparticle technology to enhance phosphate binding potency [3][4]. Product Details - OLC aims to reduce the pill burden for patients, potentially improving adherence compared to existing treatments [3]. - The NDA submission for OLC is based on data from three clinical studies and multiple preclinical studies, with a strong global patent portfolio protecting the product until at least 2031, with potential extensions until 2035 [4]. Market Context - Hyperphosphatemia is a critical condition affecting nearly all patients with End Stage Renal Disease (ESRD), with over 450,000 individuals in the U.S. requiring medication annually to manage phosphate levels [5]. - Effective treatment of hyperphosphatemia is essential to reduce associated risks of increased mortality and hospitalization in CKD patients on dialysis [5].

Company Overview - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney disease [3] - The company's lead drug candidate, oxylanthanum carbonate (OLC), is designed to treat hyperphosphatemia in chronic kidney disease patients on dialysis [3] - OLC has shown positive pivotal trial results reported in June 2024, and a New Drug Application (NDA) is currently under review by the U.S. FDA with a target action date of June 28, 2025 [3] Intellectual Property - OLC is protected by a strong global patent portfolio, including an issued patent on composition of matter with exclusivity until 2031, and potential patent term extension until 2035 after approval [3] - The second asset, UNI-494, is a new chemical entity in clinical development for acute kidney injury, which has successfully completed a Phase 1 trial [3] Upcoming Events - Shalabh Gupta, M.D., CEO of Unicycive, will present at the 24th Annual Needham Virtual Healthcare Conference on April 7, 2025, at 2:15 p.m. ET [1] - A live and archived webcast of the presentation will be available on the Unicycive website under the Investors section [2]

Core Insights - Unicycive Therapeutics is presenting patient-reported outcomes data from its pivotal UNI-OLC-201 clinical study on oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis [1][2] - The New Drug Application (NDA) for OLC has been accepted by the FDA, with a target action date set for June 28, 2025 [2][9] - Hyperphosphatemia remains uncontrolled in 75% of U.S. dialysis patients, highlighting a significant unmet need for more effective treatments [3][7] Company Overview - Unicycive Therapeutics is focused on developing novel treatments for kidney diseases, with OLC as its lead drug candidate [9] - OLC utilizes proprietary nanoparticle technology to reduce pill burden, potentially improving patient adherence [2][5] - The company has a strong global patent portfolio for OLC, with exclusivity until 2031 and potential extension until 2035 [7][9] Market Opportunity - The market for treating hyperphosphatemia is projected to exceed $2.28 billion, with North America accounting for over $1 billion [7] - Despite existing phosphate binders, 75% of dialysis patients do not achieve target phosphorus levels, indicating a substantial market gap [7][8] Clinical Study Insights - OLC has shown the potential to reduce pill burden by half, which is a key factor in improving adherence among dialysis patients [6][8] - The upcoming medical meetings will feature abstracts related to the pivotal clinical study, emphasizing the importance of addressing pill burden in treatment [4][6]